A Single-Center Randomized, Double-Blind, Placebo-Controlled Phase 1 Trial to Assess the Safety and Tolerability of Single and Multiple Daily Oral Administration of STP206 Live Biotherapeutic in Healthy Adult Subjects

Subjects with history of immune compromised conditions or any past use of immunosuppressant treatment

Subjects with current or past history of gastrointestinal disease, including any conditions with increased risk for bleeding (e.g., gingivitis, hemorrhoids)

Subjects who are lactose intolerant

Subjects who are intolerant or allergic to Splenda® or any of its ingredients (dextrose, maltodextrin, sucralose) or have a soy allergy

Subjects who have had a fever of 100°F or higher within the 2 weeks of the first dose of study drug

Subjects who have received a "live" vaccine within 30 days of the first dose of study drug

Subjects who have received any medications (prescription or OTC) within 2 weeks of the first dose of study drug

Subjects who have received and investigational drug with 30 days prior to the first dose of study drug

Subjects with a history of illicit drug use or alcohol abuse

Subjects with any other medical condition that may influence the objectives or outcomes of the study

Female subjects who are pregnant or lactating

Female subjects of childbearing potential who are not using an FDA approved birth control method

Subjects who are healthcare or daycare providers or those with close contact with immune compromised individuals

Subjects with a history of acute hepatitis, HIV infection or known to have positive diagnostic tests for HIV or HBV

Subjects who have a planned dental appointment from screening through 7 days after last dose of Investigational Product.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922324